BridgeMD
Glenzocimab for REperfusion in the setting of Endovascular therapy for brain infarctioN
EU CTIS ID: 2024-514352-32-00
What this study is testing
To evaluate the efficacy of glenzocimab in addition to EVT and compared to EVT plus placebo, whether or not associated with IVT, on functional outcome at day 90.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age 18 years or older (Age≥18 years)
- 2. No significant pre-stroke disability (pre-stroke mRS must be equal to 0 or 1);
- 3.Indication of EVT within the time-window of 0 to 24 hrs in participants, treated with or without intravenous thrombolysis, and presenting with a clinico-radiological mismatch (defined by a NIHSS≥10 and an ASPECT score≥6)
- 4. Occlusion of the cervical or intracranial internal carotid artery (ICA) or the proximal middle cerebral artery (MCA - M1 and/or M2), on magnetic resonance angiography (MRA) or, when this is not possible, on CT angiography (CTA);
- 5. Informed consent signed: • By the patient, • Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent by written as per L. 1111-6, • In a situation urgently and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent.
- 6. Post-menopausal women defined as not having menses for 12 months without an alternative medical cause. For WOCBP, a highly effective birth control method should be in place that can achieve a failure rate of less than 1% per year that should last for at least 2 months after IMP administration.
You likely can't join if
- 1. Contraindications to EVT;
- 10. Pregnant or breastfeeding woman;
- 11. Known hypersensitivity to glenzocimab or to any of the excipients;
- 12. Known Severe renal insufficiency (Grades 4-5) with a glomerular filtration rate < 30mL/Min/1.73m2;
- 13. Participation in another interventional clinical trial within 30 days prior to the inclusion.
- 14. Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under sections L.3212-1 et L.3213-1 and persons admitted to a health or social institution for purposes other than research (L.1121-6)
See the full eligibility criteria
Who can join
- 1. Age 18 years or older (Age≥18 years)
- 2. No significant pre-stroke disability (pre-stroke mRS must be equal to 0 or 1);
- 3.Indication of EVT within the time-window of 0 to 24 hrs in participants, treated with or without intravenous thrombolysis, and presenting with a clinico-radiological mismatch (defined by a NIHSS≥10 and an ASPECT score≥6)
- 4. Occlusion of the cervical or intracranial internal carotid artery (ICA) or the proximal middle cerebral artery (MCA - M1 and/or M2), on magnetic resonance angiography (MRA) or, when this is not possible, on CT angiography (CTA);
- 5. Informed consent signed: • By the patient, • Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent by written as per L. 1111-6, • In a situation urgently and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent.
- 6. Post-menopausal women defined as not having menses for 12 months without an alternative medical cause. For WOCBP, a highly effective birth control method should be in place that can achieve a failure rate of less than 1% per year that should last for at least 2 months after IMP administration.
- 7. Women of child-bearing potential (WOCBP) must have a negative serum/urine pregnancy test at baseline. Women of childbearing potential, i.e., fertile, are defined as women following menarche and until becoming post-menopausal unless permanently sterile, i.e., having undergone hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- 8. Affiliation to social security or any health insurance
What rules you out
- 1. Contraindications to EVT;
- 10. Pregnant or breastfeeding woman;
- 11. Known hypersensitivity to glenzocimab or to any of the excipients;
- 12. Known Severe renal insufficiency (Grades 4-5) with a glomerular filtration rate < 30mL/Min/1.73m2;
- 13. Participation in another interventional clinical trial within 30 days prior to the inclusion.
- 14. Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under sections L.3212-1 et L.3213-1 and persons admitted to a health or social institution for purposes other than research (L.1121-6)
- 15. Adults subject to a legal protection measure (L.1121-8)
- 16. The patient or his/her family (if the patient is unable to give his/her opinion) expresses an inability to return for protocol visits
- 17. patients receiving anticoagulants (i.e. heparin within 48 hours and an elevated aPTT -greater than upper limit of normal for laboratory-; (current use of oral anticoagulants (ex: warfarin) and INR >1.7; Current use of direct thrombin inhibitors or direct factor Xa inhibitors, as already mentioned in the non-authorized concomitant treatments
- 18. patients who have already received another humanized fragment of monoclonal antibody with a suspicion of hypersensitivity
- 2. Contraindication to contrast agents
- 3. Pre-existing neurologic and psychiatric disease with mRS ≥ 2;
- 4. Unknown symptom’s onset or last seem well > 24 hours;
- 5. Patients under or needing immediate DAPT administration;
- 6. Significant mass effect with midline shift as confirmed on CT/MRI;
- 7. Gastrointestinal or urinary tract hemorrhage in previous 21 days;
- 8. Patient with intracranial haemorrhage
- 9. Known Platelet count <100 000 mm3
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.